AFFINITY Phase 2 MS trial begins

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Biogen has announced the recent initiation of the Phase 2 clinical trial AFFINITY, designed to evaluate opicinumab—a human monoclonal antibody targeting LINGO-1—as an investigational add-on therapy in people with relapsing forms of multiple sclerosis (RMS). The trial follows a post-hoc analysis of SYNERGY, a Phase 2 trial, which identified a specific population of patients with RMS that may be more likely to benefit from the investigational therapy.

These data were presented at MSParis2017, the seventh Joint Meeting of the European Committee for Treatment and Research in MS and Americas Committee for Treatment and Research in MS (ECTRIMS-ACTRIMS; 25th – 28th October).

SYNERGY post-hoc analysis identifies predictive characteristics associated with increased treatment effect

A post-hoc analysis of SYNERGY indicated an increased clinical effect of opicinumab versus placebo (when used at the same time as interferon beta-1a intramuscular injection [IM IFN beta-1a]) in a subgroup of patients with RMS. The subpopulation had the disease for no more than 20 years and brain magnetic resonance imagery (MRI) features at baseline suggestive of relative myelin loss and greater structural integrity. This was indicated by the baseline magnetisation transfer ratio and diffusion tensor imaging-radial diffusivity values in pre-existing T2 lesions in these patients. Of the subpopulation with these characteristics, 81% of patients treated with 10mg/kg opicinumab and IM IFN beta-1a, versus 36% for placebo and IM IFN beta-1a, showed 12-week confirmed improvement over 72 weeks in at least one of the assessments of a multicomponent measure evaluating improvement of physical function, cognitive function, and disability. These assessments were the expanded disability status scale, timed 25-foot walk, 9-hole peg test and 3-second paced auditory serial addition test. The post-hoc subgroup data demonstrate that a more targeted approach for opicinumab treatment warrants further investigation.

AFFINITY trial design informed by identification of more treatment-responsive subgroup in SYNERGY

The recently-initiated AFFINITY study is a multicentre, randomised, double-blind, placebo-controlled, Phase 2 study that aims to enrol 240 people with RMS. It will evaluate opicinumab as an add-on investigational therapy in patients with RMS who are adequately controlled on their anti-inflammatory disease-modifying therapy (DMT), versus the DMT alone. The primary endpoint of the study, Overall Response Score, is an integrated measure of both the improvement and worsening of disability over time.

“When analysing the SYNERGY results, we discovered which patients with relapsing MS may be more responsive to opicinumab, and this became a significant component of the trial design for AFFINITY,” says Professor Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry, UK. “We now have an exciting opportunity to apply a more precise biological approach when evaluating the potential of opicinumab as a therapy that may improve patients’ disability and lead to a better overall outcome.”

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